FDA 510(k) Application Details - K053363

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K053363
Device Name	Electrode, Cortical
Applicant	AD-TECH MEDICAL INSTRUMENT CORP. 800 LEVANGER LANE STOUGHTON, WI 53589 US Other 510(k) Applications for this Company
Contact	Gary Syring Other 510(k) Applications for this Contact
Regulation Number	882.1310   More FDA Info for this Regulation Number
Classification Product Code	GYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2005
Decision Date	05/30/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review